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Use of Breast MRI for Local Staging

This study has been withdrawn prior to enrollment.
(There were no subjects ever enrolled. Study was closed at the IRB.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00579319
First Posted: December 24, 2007
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Arkansas
  Purpose
When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Use of Breast MRI for Local Staging

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Breast MRI will have a significant impact on patient management [ Time Frame: at time of staging ]

Enrollment: 0
Study Start Date: April 2005
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

When breast MRI is used to determine the extent of local disease, the management changes, resulting in improved outcomes. Studies have indicated that breast MRI plus mammography is better for detecting tumors. surgeons are now utilizing breast MRI to determine the extent of disease in women diagnosed with breast cancer. It has not been established how management of breast cancer patients has been affected by the use of breast MRI or how that management has affected the outcome for these patients. This retrospective chart review will document management and outcome for breast cancer patients who have had pre treatment breast MRI.

The medical records of patients who received breast MRI for pre—treatment staging of breast cancer will be retrospectively reviewed to see if the MRI information affected management. UAMS surgeons will be asked if the breast MRI resulted in:

  1. no change in management
  2. Moderate change in management−what (modified lumpectomy−larger or smaller)
  3. Significant change−what (contralateral breast, additional quadrants, lump to mast, neoadjuvant chemo)−note less dz than w/o MRI, more dz than w/o MRI. The medical record of patients who were imaged will be reviewed for presenting symptom, clinical exam, imaging studies (mammogram, breast ultrasound, breast MRi) and pathology results. This study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of PHI. To minimize this risk, data collection forms will be identified by subject ID number. A master list of these ID numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. The medical record number will not be recorded on any other form containing subject PHI. The only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing breast MRI at a community practice in Northwest Arkansas
Criteria

Inclusion Criteria:

  • Patients who have undergone a breast MRI for staging

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579319


Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Steven E Harms, MD UAMS
  More Information

Responsible Party: Steven E. Harms, MD, UAMS
ClinicalTrials.gov Identifier: NCT00579319     History of Changes
Other Study ID Numbers: 37639
First Submitted: December 20, 2007
First Posted: December 24, 2007
Last Update Posted: March 4, 2015
Last Verified: March 2015

Keywords provided by University of Arkansas:
breast cancer